A Study of Subcutaneous Mircera for the Treatment of Anem... | NCT00077623

NCT00077623

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
RO0503821 (1x/2 Weeks)	Experimental	Eligible participants received RO0503821 (Mircera [methoxy polyethylene glycol-epoetin beta]) subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 microgram (mcg) which was based on the epoetin dose of<8000, 8000-16000, or >16000 international units (IU)/week, administered during the week preceding the switch to the study drug.	Drug: methoxy polyethylene glycol-epoetin beta (Mircera)
RO0503821 (1x/4 Weeks)	Experimental	Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week administered during the week preceding the switch to the study drug.	Drug: methoxy polyethylene glycol-epoetin beta (Mircera)
Epoetin Reference	Active Comparator	Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks .	Drug: epoetin alfa or beta

Name	Type	Description	Arm Group Labels	Other Names
epoetin alfa or beta	Drug	iv 3 times weekly, as prescribed	Epoetin Reference

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean Change in Hemoglobin Concentration From Baseline to Evaluation Periods	A time adjusted mean change in hemoglobin (Hb) concentration was calculated using an area under the curve (AUC) approach, for both periods separately. Change in Hb concentration between the baseline and evaluation periods was calculated by subtracting the calculated average baseline Hb value from the average evaluation period Hb value. All blood samples for Hb measurements were taken prior to study drug administration. Analysis used last observation carried forward (LOCF) for missing Hb values to correct for the impact of early dropouts. The baseline period is defined as Week -4 to Week -1. The evaluation period is defined as Week 29 to Week 36.	Baseline (Week -4 to Week -1) and Evaluation period (Week 29 to Week 36)

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants Maintaining Average Hb Concentration During the Evaluation Period Within +-1 g/dL of Their Average Baseline Hb Concentration	All mean Hb values recorded during the evaluation period were calculated and subtracted from the mean baseline Hb value for each participant. The number of participants maintaining their average Hb within +/- 1 g/dL of their average baseline hemoglobin concentration is given. The evaluation period is defined as Week 29 to Week 36.

Eligibility Module

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Hot Springs	Arkansas	71901	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36791280	Derived	Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	RO0503821 (1x/2 Weeks)	Eligible participants received RO0503821 (Mircera [methoxy polyethylene glycol-epoetin beta]) subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 microgram (mcg) which was based on the epoetin dose of<8000, 8000-16000, or >16000 international units per week (IU/week), administered during the week preceding the switch to the study drug.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	RO0503821 (1x/2 Weeks)	Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the Epoetin dose of<8000, 8000-16000,or >16000 International units [IU]/Week, administered during the week preceding the switch to the study drug.
BG001	RO0503821 (1x/4 Weeks)	Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the Epoetin dose of<8000, 8000-16000, or >16000 IU/Week administered during the week preceding the switch to the study drug.
BG002	Epoetin Reference	Eligible participants received their ongoing weekly subcutaneous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG000-0.00± 0.96 OG001-0.11± 0.97 OG002-0.12± 1.04

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002	The non-inferiority test for treatment differences in Hb change from baseline, based on ANCOVA analysis with a non-inferiority limit of -0.75 g/dL (Per Protocol Population)	ANCOVA, CI for difference between groups		<0.0001	The p-value for the non-inferiority test can be derived via the t-test.	Mean Difference between groups	0.141			2-Sided	97.5	-0.098	0.380				Yes	Non-Inferiority or Equivalence	The two RO0503821 dosing schedules were compared separately to epoetin reference using ANCOVA, with Hb at BL and region as the covariates. The test for non-inferiority were based on the lower limit of the two-sided 97.5% confidence interval for the difference between the two groups. When the lower limit was greater than or equal to -0.75 g/dL, the RO0503821 groups were regarded as non-inferior to the epoetin reference group. The confidence level of 97.5% was chosen to adjust for multiplicity.

Secondary

Number of Participants Maintaining Average Hb Concentration During the Evaluation Period Within +-1 g/dL of Their Average Baseline Hb Concentration

All mean Hb values recorded during the evaluation period were calculated and subtracted from the mean baseline Hb value for each participant. The number of participants maintaining their average Hb within +/- 1 g/dL of their average baseline hemoglobin concentration is given. The evaluation period is defined as Week 29 to Week 36.

The Intent-to-Treat (ITT) population included all randomized participants.

Posted

Number

participants

Evaluation period (Week 29 to Week 36)

ID	Title	Description
OG000	RO0503821 (1x/2 Weeks)	Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week, administered during the week preceding the switch to the study drug.
OG001	RO0503821 (1x/4 Weeks)	Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week administered during the week preceding the switch to the study drug.
OG002

Secondary

Number of Participants With Red Blood Cell Transfusions

The number of participants who received RBC transfusions were reported.

Safety population included all participants who received at least one dose of study drug.

Posted

Number

participants

Up to Week 36

ID	Title	Description
OG000	RO0503821 (1x/2 Weeks)	Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week, administered during the week preceding the switch to the study drug.
OG001	RO0503821 (1x/4 Weeks)	Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week administered during the week preceding the switch to the study drug.
OG002	Epoetin Reference	Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks.

Secondary

Number of Participants With Any Adverse Events, Any Serious Adverse Events, and Deaths

An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Safety population included all participants who received at least one dose of study drug.

Posted

Number

participants

Up to week 52

ID	Title	Description
OG000	RO0503821 (1x/2 Weeks)	Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week, administered during the week preceding the switch to the study drug.
OG001	RO0503821 (1x/4 Weeks)	Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week administered during the week preceding the switch to the study drug.

Secondary

Number of Participants With Marked Laboratory Abnormalities

A marked abnormality range was defined as above and/or below a value which was considered to be potentially clinically relevant. Marked laboratory abnormalities were analyzed according to the Roche specified limits for the reference range of the following laboratory parameters: White blood cells (WBC) (3.0- 18.0 10^9/L), platelets (100 - 550 10^9/L), alanine aminotransferase (ALAT) (0 - 110 units per liter [U/L]), alkaline phosphatase (ALP [0 - 220 U/L]), aspartate aminotransferase (ASAT) (0 - 80 U/L), albumin >= 30 g/L, phosphate (0.75 - 1.60 millimoles per liter [mmol/L]), potassium (2.9 - 5.8 mmol/L), glucose (2.80 - 11.10 mmol/L).

Safety population included all participants who received at least one dose of study drug. Maximum number of participants available at the time of assessment were denoted as 'n'.

Posted

Number

participants

Up to week 52

ID	Title	Description
OG000	RO0503821 (1x/2 Weeks)	Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week, administered during the week preceding the switch to the study drug.
OG001	RO0503821 (1x/4 Weeks)	Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week administered during the week preceding the switch to the study drug.

Secondary

Change From Baseline in Systolic and Diastolic Blood Pressure - at Weeks 36 and 52 in Hemodialysis Participants

Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was measured in sitting position before and after dialysis session in haemodialysis participants.

Safety population included all participants who received at least one dose of study drug. Maximum number of participants available at the time of assessment was denoted as 'n'.

Posted

Mean

Standard Deviation

mmHG

From Baseline (Week -4 to Week -1) to Week 36 and Week 52

ID	Title	Description
OG000	RO0503821 (1x/2 Weeks)	Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week, administered during the week preceding the switch to the study drug.
OG001	RO0503821 (1x/4 Weeks)	Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week administered during the week preceding the switch to the study drug.
OG002	Epoetin Reference

Secondary

Change From Baseline in Pulse Rate at Weeks 36 and 52 in Hemodialysis Participants

Pulse rate in beats per minute (BpM) was measured at each study visit, i.e., once a week during the dose titration and evaluation periods, once every two weeks during the long-term safety observation period and at the final visit. It was measured before blood sampling and RO0503821/epoetin administration and before the dialysis session in haemodialysis participants.

Safety population included all participants who received at least one dose of study drug. Maximum number of participants available at the time of assessment was denoted as 'n'.

Posted

Mean

Standard Deviation

BpM

From Baseline (Week -4 to Week -1) to Week 36 and Week 52

ID	Title	Description
OG000	RO0503821 (1x/2 Weeks)	Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week, administered during the week preceding the switch to the study drug.
OG001	RO0503821 (1x/4 Weeks)	Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week administered during the week preceding the switch to the study drug.

Secondary

Change From Baseline in Systolic and Diastolic Blood Pressure at Weeks 36 and 52 in Peritoneal Dialysis Participants

Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was measured in sitting position before and after dialysis session in peritoneal dialysis participants.

Safety population included all participants who received at least one dose of study medication. Maximum number of participants available at the time of assessment were analysed and reported.

Posted

Mean

Standard Deviation

mm HG

From Baseline (Week -4 to Week -1) to Week 36 and Week 52

ID	Title	Description
OG000	RO0503821 (1x/2 Weeks)	Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week, administered during the week preceding the switch to the study drug.
OG001	RO0503821 (1x/4 Weeks)	Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week administered during the week preceding the switch to the study drug.
OG002	Epoetin Reference

Secondary

Change From Baseline in Pulse Rate - Peritoneal Dialysis Participants

Pulse rate in BpM was measured at each study visit, i.e., once a week during the dose titration and evaluation periods, once every two weeks during the long-term safety observation period and at the final visit. It was measured before blood sampling and RO0503821/epoetin administration and before the dialysis session in peritoneal dialysis participants.

Safety population included all participants who received at least one dose of study drug. Maximum number of participants available at the time of assessment was denoted as 'n'.

Posted

Mean

Standard Deviation

BpM

From Baseline (Week -4 to Week -1) to Week 36 and Week 52

ID	Title	Description
OG000	RO0503821 (1x/2 Weeks)	Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week, administered during the week preceding the switch to the study drug.
OG001	RO0503821 (1x/4 Weeks)	Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week administered during the week preceding the switch to the study drug.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	RO0503821 (1x/2 Weeks)	Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week, administered during the week preceding the switch to the study drug.	70	190	113	190
EG001	RO0503821 (1x/4 Weeks)	Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week administered during the week preceding the switch to the study drug.	73	190	131	190
EG002	Epoetin Reference	Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks.	85	191	111	191

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pneumonia	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0005 affected190 at risk EG0015 affected190 at risk EG0028 affected191 at risk
Gangrene	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0002 affected190 at risk EG0011 affected190 at risk EG0022 affected191 at risk
Sepsis	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0002 affected190 at risk EG0013 affected190 at risk EG0020 affected191 at risk
Staphylococcal Bacteraemia	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0024 affected191 at risk
Bronchitis Acute	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0012 affected190 at risk EG0021 affected191 at risk
Bronchopneumonia	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0014 affected190 at risk EG0020 affected191 at risk
Gastroenteritis	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0002 affected190 at risk EG0011 affected190 at risk EG0021 affected191 at risk
Septic Shock	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0013 affected190 at risk EG0020 affected191 at risk
Catheter Related Infection	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0022 affected191 at risk
Peritonitis bacterial	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0002 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Pneumonia bacterial	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0011 affected190 at risk EG0021 affected191 at risk
Staphylococcal infection	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0022 affected191 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0022 affected191 at risk
Bronchitis	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0021 affected191 at risk
Cellulitis	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Diverticulitis	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0021 affected191 at risk
Escherichia sepsis	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0021 affected191 at risk
Infected skin ulcer	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0022 affected191 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0012 affected190 at risk EG0020 affected191 at risk
Abdominal infection	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Appendicitis	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Arteriovenous fistula site infection	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Arteriovenous graft site abscess	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Arteriovenous graft site infection	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Arthritis bacterial	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0020 affected191 at risk
Bacterial infection	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Bacterial sepsis	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Catheter site infection	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Cellulitis gangrenous	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Cellulitis of male external genital organ	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Diabetic foot infection	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Diarrhoea infectious	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Endocarditis	Immune system disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Escherichia infection	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0020 affected191 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Fungal infection	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Hepatitis c	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Herpes ophthalmic	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Herpes zoster	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Influenza	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Intestinal gangrene	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0020 affected191 at risk
Klebsiella sepsis	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Otitis externa	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Pneumonia chlamydial	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Postoperative wound infection	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Pseudomonas infection	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Pyelonephritis	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Pyelonephritis acute	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Respiratory tract infection	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Scrotal abscess	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0020 affected191 at risk
Sepsis syndrome	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0020 affected191 at risk
Serratia sepsis	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Staphylococcal abscess	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0020 affected191 at risk
Tuberculosis	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0020 affected191 at risk
Urinary tract infection	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0020 affected191 at risk
Myocardial infarction	Cardiac disorders	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0018 affected190 at risk EG0026 affected191 at risk
Cardiac arrest	Cardiac disorders	MedDRA (8.1)	Systematic Assessment	EG0002 affected190 at risk EG0014 affected190 at risk EG0024 affected191 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA (8.1)	Systematic Assessment	EG0002 affected190 at risk EG0015 affected190 at risk EG0023 affected191 at risk
Angina pectoris	Cardiac disorders	MedDRA (8.1)	Systematic Assessment	EG0002 affected190 at risk EG0013 affected190 at risk EG0022 affected191 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0011 affected190 at risk EG0022 affected191 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (8.1)	Systematic Assessment	EG0003 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Coronary artery disease	Cardiac disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0022 affected191 at risk
Angina unstable	Cardiac disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0021 affected191 at risk
Arrhythmia	Cardiac disorders	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Atrial flutter	Cardiac disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0022 affected191 at risk
Bradyarrhythmia	Cardiac disorders	MedDRA (8.1)	Systematic Assessment	EG0002 affected190 at risk EG0010 affected190 at risk EG0020 affected191 at risk
Cardiac failure	Cardiac disorders	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0022 affected191 at risk
Coronary artery atherosclerosis	Cardiac disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0021 affected191 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0021 affected191 at risk
Pericarditis	Cardiac disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0021 affected191 at risk
Sick sinus syndrome	Cardiac disorders	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0021 affected191 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Atrioventricular block	Cardiac disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Cardiac failure acute	Cardiac disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Coronary artery dissection	Cardiac disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Coronary artery insufficiency	Cardiac disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Coronary artery thrombosis	Cardiac disorders	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0020 affected191 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0020 affected191 at risk
Tachycardia	Cardiac disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Arteriovenous fistula thrombosis	Injury, poisoning and procedural complications	MedDRA (8.1)	Systematic Assessment	EG0004 affected190 at risk EG0013 affected190 at risk EG0023 affected191 at risk
Arteriovenous fistula site haemorrhage	Injury, poisoning and procedural complications	MedDRA (8.1)	Systematic Assessment	EG0004 affected190 at risk EG0010 affected190 at risk EG0020 affected191 at risk
Arteriovenous graft thrombosis	Injury, poisoning and procedural complications	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0022 affected191 at risk
Procedural hypotension	Injury, poisoning and procedural complications	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0011 affected190 at risk EG0021 affected191 at risk
Arteriovenous fistula site complication	Injury, poisoning and procedural complications	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Arteriovenous graft site haemorrhage	Injury, poisoning and procedural complications	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0012 affected190 at risk EG0020 affected191 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA (8.1)	Systematic Assessment	EG0002 affected190 at risk EG0010 affected190 at risk EG0020 affected191 at risk
Eye injury	Injury, poisoning and procedural complications	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0022 affected191 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0012 affected190 at risk EG0020 affected191 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0022 affected191 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Anaemia postoperative	Injury, poisoning and procedural complications	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0020 affected191 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0020 affected191 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Dislocation of joint prosthesis	Injury, poisoning and procedural complications	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Fracture	Injury, poisoning and procedural complications	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Jaw fracture	Injury, poisoning and procedural complications	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0020 affected191 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0020 affected191 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0020 affected191 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0020 affected191 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0020 affected191 at risk
Vascular bypass dysfunction	Injury, poisoning and procedural complications	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Vascular graft occlusion	Injury, poisoning and procedural complications	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0020 affected191 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (8.1)	Systematic Assessment	EG0004 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Constipation	Gastrointestinal disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0022 affected191 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (8.1)	Systematic Assessment	EG0002 affected190 at risk EG0010 affected190 at risk EG0020 affected191 at risk
Gastritis haemorrhagic	Gastrointestinal disorders	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0021 affected191 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0020 affected191 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Anal fissure	Gastrointestinal disorders	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0020 affected191 at risk
Bezoar	Gastrointestinal disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Diabetic gastroparesis	Gastrointestinal disorders	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0020 affected191 at risk
Diverticulum intestinal haemorrhagic	Gastrointestinal disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Duodenitis haemorrhagic	Gastrointestinal disorders	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0020 affected191 at risk
Erosive duodenitis	Gastrointestinal disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0020 affected191 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Gastritis	Gastrointestinal disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Gastroduodenal ulcer	Gastrointestinal disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Gastrointestinal necrosis	Gastrointestinal disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Ileus	Gastrointestinal disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Peritoneal haematoma	Gastrointestinal disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Peritonitis	Gastrointestinal disorders	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0020 affected191 at risk
Thrombosis mesenteric vessel	Gastrointestinal disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0020 affected191 at risk
Vomiting	Gastrointestinal disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Atherosclerosis obliterans	Vascular disorders	MedDRA (8.1)	Systematic Assessment	EG0002 affected190 at risk EG0011 affected190 at risk EG0021 affected191 at risk
Hypotension	Vascular disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0014 affected190 at risk EG0020 affected191 at risk
Atherosclerosis	Vascular disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0021 affected191 at risk
Hypertension	Vascular disorders	MedDRA (8.1)	Systematic Assessment	EG0002 affected190 at risk EG0010 affected190 at risk EG0020 affected191 at risk
Hypertensive crisis	Vascular disorders	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Intermittent claudication	Vascular disorders	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Peripheral ischaemia	Vascular disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0022 affected191 at risk
Peripheral occlusive disease	Vascular disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0012 affected190 at risk EG0020 affected191 at risk
Circulatory collapse	Gastrointestinal disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Deep vein thrombosis	Gastrointestinal disorders	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0020 affected191 at risk
Diabetic vascular disorder	Vascular disorders	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0020 affected191 at risk
Iliac artery stenosis	Vascular disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Lymphoedema	Vascular disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Orthostatic hypotension	Vascular disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Peripheral embolism	Vascular disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Ischaemic stroke	Nervous system disorders	MedDRA (8.1)	Systematic Assessment	EG0002 affected190 at risk EG0012 affected190 at risk EG0022 affected191 at risk
Toxic induced encephalopathy	Nervous system disorders	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Brain stem haemorrhage	Nervous system disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Cerebral artery embolism	Nervous system disorders	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0020 affected191 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Cerebrovascular insufficiency	Nervous system disorders	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0020 affected191 at risk
Convulsion	Nervous system disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Dizziness	Nervous system disorders	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0020 affected191 at risk
Facial palsy	Nervous system disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Headache	Nervous system disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Hypoglycaemic coma	Nervous system disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Hypoxic encephalopathy	Nervous system disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Loss of consciousness	Nervous system disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Sciatica	Nervous system disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Syncope vasovagal	Nervous system disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Thrombotic stroke	Nervous system disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0014 affected190 at risk EG0023 affected191 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0024 affected191 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0011 affected190 at risk EG0022 affected191 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0012 affected190 at risk EG0020 affected191 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0020 affected191 at risk
Hyperkalaemia	Musculoskeletal and connective tissue disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0022 affected191 at risk
Parathyroid tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Metastatic renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Neoplasm skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0020 affected191 at risk
Parathyroid tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0020 affected191 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0020 affected191 at risk
Rectal adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Renal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0020 affected191 at risk
Renal cell carcinoma stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0020 affected191 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0020 affected191 at risk
Thyroid gland cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0020 affected191 at risk
Calculus bladder	Renal and urinary disorders	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Renal failure chronic	Renal and urinary disorders	MedDRA (8.1)	Systematic Assessment	EG0002 affected190 at risk EG0010 affected190 at risk EG0020 affected191 at risk
Bladder cyst	Renal and urinary disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Bladder tamponade	Renal and urinary disorders	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0020 affected191 at risk
Cystitis noninfective	Renal and urinary disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Pyelectasia	Renal and urinary disorders	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0020 affected191 at risk
Renal cyst	Renal and urinary disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Renal failure	Renal and urinary disorders	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0020 affected191 at risk
Renal haemorrhage	Renal and urinary disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Urinary bladder haemorrhage	Renal and urinary disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Chest pain	General disorders	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0011 affected190 at risk EG0021 affected191 at risk
Fatigue	General disorders	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Catheter related complication	General disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Catheter site haemorrhage	General disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Hyperthermia	General disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Ischaemic ulcer	General disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Multi-organ failure	General disorders	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0020 affected191 at risk
Pyrexia	General disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Sudden death	General disorders	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0020 affected191 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0011 affected190 at risk EG0021 affected191 at risk
Pneumothorax	General disorders	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0020 affected191 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0020 affected191 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Monarthritis	Musculoskeletal and connective tissue disorders	MedDRA (8.1)	Systematic Assessment	EG0002 affected190 at risk EG0010 affected190 at risk EG0020 affected191 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Chondrocalcinosis pyrophosphate	Musculoskeletal and connective tissue disorders	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0020 affected191 at risk
Haemarthrosis	Musculoskeletal and connective tissue disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (8.1)	Systematic Assessment	EG0002 affected190 at risk EG0012 affected190 at risk EG0021 affected191 at risk
Cholestasis	Hepatobiliary disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0020 affected191 at risk
Cataract	Eye disorders	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0011 affected190 at risk EG0021 affected191 at risk
Retinal detachment	Eye disorders	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Diabetic retinopathy	Eye disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Cervix disorder	Reproductive system and breast disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Metrorrhagia	Reproductive system and breast disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Pelvic pain	Reproductive system and breast disorders	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0020 affected191 at risk
Penile necrosis	Reproductive system and breast disorders	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0020 affected191 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0022 affected191 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Leukocytoclastic vasculitis	Skin and subcutaneous tissue disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Skin necrosis	Skin and subcutaneous tissue disorders	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0020 affected191 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0020 affected191 at risk
Anxiety	Psychiatric disorders	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0020 affected191 at risk
Cognitive deterioration	Psychiatric disorders	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0020 affected191 at risk
Confusional state	Psychiatric disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Disorientation	Psychiatric disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Drug dependence	Psychiatric disorders	MedDRA (8.1)	Systematic Assessment	EG0001 affected190 at risk EG0010 affected190 at risk EG0020 affected191 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Anaemia vitamin b12 deficiency	Blood and lymphatic system disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Aplasia pure red cell	Blood and lymphatic system disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk
Adrenal cortical insufficiency	Endocrine disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0011 affected190 at risk EG0020 affected191 at risk
Hypothyroidism	Endocrine disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG0010 affected190 at risk EG0021 affected191 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Procedural hypotension	Injury, poisoning and procedural complications	MedDRA (8.1)	Systematic Assessment	EG00016 affected190 at risk EG00128 affected190 at risk EG00219 affected191 at risk
Arteriovenous fistula site haemorrhage	Injury, poisoning and procedural complications	MedDRA (8.1)	Systematic Assessment	EG00014 affected190 at risk EG00115 affected190 at risk EG0025 affected191 at risk
Arteriovenous fistula thrombosis	Injury, poisoning and procedural complications	MedDRA (8.1)	Systematic Assessment	EG00011 affected190 at risk EG00113 affected190 at risk EG0026 affected191 at risk
Arteriovenous fistula site complication	Injury, poisoning and procedural complications	MedDRA (8.1)	Systematic Assessment	EG0006 affected190 at risk EG00111 affected190 at risk EG0029 affected191 at risk
Procedural hypertension	Injury, poisoning and procedural complications	MedDRA (8.1)	Systematic Assessment	EG0007 affected190 at risk EG00113 affected190 at risk EG0024 affected191 at risk
Nasopharyngitis	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG00018 affected190 at risk EG00119 affected190 at risk EG00218 affected191 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG00012 affected190 at risk EG00112 affected190 at risk EG00211 affected191 at risk
Bronchitis	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0006 affected190 at risk EG00113 affected190 at risk EG00211 affected191 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (8.1)	Systematic Assessment	EG00016 affected190 at risk EG00114 affected190 at risk EG00217 affected191 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (8.1)	Systematic Assessment	EG00011 affected190 at risk EG0018 affected190 at risk EG00210 affected191 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (8.1)	Systematic Assessment	EG0005 affected190 at risk EG00113 affected190 at risk EG00210 affected191 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (8.1)	Systematic Assessment	EG0002 affected190 at risk EG00111 affected190 at risk EG0025 affected191 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (8.1)	Systematic Assessment	EG00018 affected190 at risk EG00115 affected190 at risk EG00214 affected191 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (8.1)	Systematic Assessment	EG0004 affected190 at risk EG00111 affected190 at risk EG0025 affected191 at risk
Headache	Nervous system disorders	MedDRA (8.1)	Systematic Assessment	EG00015 affected190 at risk EG00119 affected190 at risk EG00219 affected191 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA (8.1)	Systematic Assessment	EG0009 affected190 at risk EG00113 affected190 at risk EG00216 affected191 at risk
Angina pectoris	Cardiac disorders	MedDRA (8.1)	Systematic Assessment	EG0000 affected190 at risk EG00113 affected190 at risk EG0022 affected191 at risk
Hypertension	Vascular disorders	MedDRA (8.1)	Systematic Assessment	EG00027 affected190 at risk EG00130 affected190 at risk EG00225 affected191 at risk

Ancestor Terms

ID	Term
D004921	Erythropoietin
D003115	Colony-Stimulating Factors
D006023	Glycoproteins
D006001	Glycoconjugates
D002241	Carbohydrates
D016298	Hematopoietic Cell Growth Factors
D016207	Cytokines
D036341	Intercellular Signaling Peptides and Proteins
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D011506	Proteins
D001685	Biological Factors

ID	Term
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

ID	Term
D000068817	Epoetin Alfa
C508420	continuous erythropoietin receptor activator